Sanofi Pasteur MSD Release: New Results Confirm That Young Women Up To The Age Of 26 Years Can Benefit From Vaccination With Gardasil(R)

February 17 2009 – New results from large clinical studies demonstrate that the protection provided by Gardasil® was comparable for young women up to 26 years whether they were part of a population that had been exposed to HPV before vaccination or not1. First benefits of vaccination were observed soon after vaccination and considerably before a reduction of cervical cancer can be seen.

In clinical trials, 3.6 years after the start of vaccination there was a similar reduction of cases of disease for both the population of women who had been exposed to HPV before vaccination and those who had not. The number of prevented cases of precancerous cervical lesions (CIN 2/3 or AIS*) was estimated to be 30 per 10,000 women in the group of unexposed women; and 40 per 10,000 in the exposed group. Precancerous cervical lesions are the immediate precursor of cervical cancer, and cervical cancer remains the second most common cause of death from cancer (after breast cancer) among young women in Europe2.

The estimated reduction of colposcopies† was 130 per 10,000 women in both groups. The reduction of abnormal Pap smears‡ was 130 per 10,000 in the unexposed group and 150 per 10,000 in the exposed.

The new results were recently presented at the 20th International Congress on Anti Cancer Treatment (ICACT) in Paris, France. They illustrate the benefit that vaccination could bring to these women. Young women in their early twenties are in fact among the highest risk of exposure to HPV.3456

In addition to cervical cancer protection through vaccination of girls and young women, vaccinating young women can reduce the suffering and the distressing uncertainty about the progression of precancerous lesions to cancer and the need for medical follow-up and surgery in the years immediately after vaccination. Health care systems would benefit from reduced expenses that would begin much earlier than the reduction of cervical cancer.

Gardasil® is the only four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.7,8,9
Global endorsement of HPV vaccination and Gardasil®

Gardasil® is now approved in 109 countries and 40 million have been distributed worldwide (by the end of December 2008). HPV vaccination is now recommended in 18 of the 19 European countries in which Sanofi Pasteur MSD markets Gardasil®, and is funded or due to be funded soon in 16 of them§. HPV vaccination is also recommended and funded in the US, Australia, New Zealand and Canada.

Gardasil® has demonstrated a good safety profile

Two and a half years after the first launch and with 40 million doses distributed worldwide (by the end of December 2008) health care professional have extensive experience with the administration of Gardasil®. Authorities around the world** have confirmed the good safety profile of Gardasil® 10,11,12,13,14,15. In January 2009, the Global Advisory Committee for Vaccine Safety (GACVS) of the World Health Organisation (WHO) stated: The safety profile is similar to that described in the clinical trials before its licensing. There is no evidence of new side effects not previously detected, in relation with the use of this vaccine16. Large clinical studies that lasted a decade and included more than 25,000 women in 33 countries have not revealed an increased risk of serious adverse events compared to placebo17,18,19. In clinical trials the most often reported adverse events were injection site reactions and fever.

Details about the new study results

These results are new analyses of Future I and II studies. In this randomised, double-blind, placebo-controlled trial, 17,622 women from 16 to 26 years of age were enrolled. Vaccine or placebo was given at day 1, month 2 and 6. The participants underwent cervicovaginal sampling at day 1. Pap testing occurred at day 1 and every 6 – 12 months for up to 48 months. The results are end of study data on the impact of Gardasil® on the different types of population included in these studies: the population of HPV naïve women (unexposed), the population of already exposed to HPV and the mixed population combining the 2 previous ones, which mixes HPV-exposed and unexposed women. This analysis is after an average follow up of 3.6 years.

Current EU indication of Gardasil®

Gardasil® is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18 (see section 5.1). The indication is based on the demonstration of efficacy of Gardasil® in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males (see section 5.1). The use of Gardasil® should be in accordance with official recommendations.

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis ,and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.